Intensive EnfuvirtideContaining Antiretroviral Therapy APOLLO ANRS 130 Intensive

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Intensive Enfuvirtide-Containing Antiretroviral Therapy APOLLO (ANRS 130)

Intensive Enfuvirtide-Containing Antiretroviral Therapy APOLLO (ANRS 130)

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Study Design: APOLLO (ANRS 130) • Background:

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Study Design: APOLLO (ANRS 130) • Background: Randomized, open label phase 3 study evaluating whether the addition of enfuvirtide to standard triple antiretroviral therapy improves immunological response in antiretroviral-naïve subjects with advanced HIV disease • Inclusion Criteria (n = 195) - Antiretroviral-naïve patients - Asymptomatic with CD 4 count <100 cells/mm 3 or stage B/C disease with CD 4 count <200 cells/mm 3 - Any HIV RNA level Enfuvirtide arm LPV/r or EFV + TDF-FTC + Enfuvirtide (n = 101) Control arm LPV/r or EFV + TDF-FTC • Treatment Arms - LPV-RTV 400/100 mg BID or EFV 600 mg QD, + TDF-FTC + Enfuvirtide 90 mg BID - LPV-RTV 400/100 mg BID or EFV 600 mg QD, + TDF-FTC Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57: 758 -65. (n = 94)

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Weeks 12 through 48: Virologic Response

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Weeks 12 through 48: Virologic Response Enfuvirtide + Standard ART HIV RNA <50 copies/m. L (%) 100 80 79 74 79 58 60 46 40 33 20 0 12 weeks 24 weeks Study Week Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57: 758 -65. 48 weeks

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Week 24: Immunologic Response Enfuvirtide +

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Week 24: Immunologic Response Enfuvirtide + Standard ART CD 4 ≥ 200 cells/mm 3 (%) 100 80 60 40 34 38 20 0 Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57: 758 -65. Standard ART

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Week 24: Immunologic Response Enfuvirtide +

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Week 24: Immunologic Response Enfuvirtide + Standard ART Median CD 4 count increase (cells/mm 3) 200 150 129 113 100 50 0 Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57: 758 -65. Standard ART

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Clinical adverse events in Either Arm

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Result Clinical adverse events in Either Arm Enfuvirtide + Standard ART arm Standard ART Any grade 92% 90% Any grade and treatment related 61% 55% Grades 3 and 4 23% 30% Grades 3 and 4 and treatment related 7% 9% Serious 28% 29% Serious and study treatment related 9% 14% AIDS events 20% 13% IRIS 15% 21% Deaths 2% 2% (n = 100) (n= 94) Clinical adverse events Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57: 758 -65.

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Conclusions: “Although inducing a more rapid virological

Intensive Enfuvirtide-containing Antiretroviral Therapy APOLLO (ANRS 130): Conclusions: “Although inducing a more rapid virological response, addition of enfuvirtide to a standard c. ART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression. ” Source: Joly V, et al. Antimicrob Agents Chemother. 2013; 57(2): 758 -65.

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U. S. Department of Health and Human Services, Health Resources & Services Administration.